Catheter insertion device

ABSTRACT

A catheter insertion device ( 10 ) includes a housing ( 12 ) with a base ( 14 ), a catheter ( 28 ), an introducer needle ( 30 ) and an actuator ( 26 ) mounted within the housing. The catheter ( 28 ) and needle ( 30 ) are coupled to the actuator ( 26 ) and movable between a first position where the catheter and needle are retracted within the housing and a second position where the catheter ( 28 ) and needle ( 30 ) extend from the housing, and where the needle retracts into the actuator when the catheter and needle reach the second position. A spring ( 90 ) is provided in the housing ( 12 ) or the actuator ( 26 ) where the spring ( 90 ) is released after deployment of the device to retract the needle ( 20 ) with respect to the catheter ( 28 ).

CROSS-REFERENCE TO RELATED APPLICATION

This application claims priority under 35 USC §119(e) from U.S.Provisional Patent Application Ser. No. 61/983,982 filed on Apr. 24,2014, the disclosure of which is incorporated herein by reference in itsentirety.

FIELD OF THE INVENTION

The present invention is directed to a catheter insertion device and toan infusion set including the catheter insertion device. The inventionis particularly directed to a catheter insertion device for use with aninfusion set or other delivery device for introducing a catheter into apatient and automatically retracting an insertion needle once thecatheter is moved to an extended position with respect to a housing ofthe device. The invention is also directed to a manually operatedcatheter insertion device where an actuator is deployed to insert thecatheter into the patient and automatically retract the insertionneedle. The invention is further directed to a method of inserting acatheter using the catheter insertion device of the invention.

BACKGROUND OF THE INVENTION

Diabetes is a group of diseases characterized by high levels of bloodglucose resulting from the inability of diabetic patients to maintainproper levels of insulin production when required. Persons with diabeteswill require some form of daily insulin therapy to maintain control oftheir glucose levels. Diabetes can be dangerous to the affected patientif it is not treated, and it can lead to serious health complicationsand premature death. However, such complications can be minimized byutilizing one or more treatment options to help control the diabetes andreduce the risk of complications.

The treatment options for diabetic patients include specialized diets,oral medications and/or insulin therapy. The main goal of diabetestreatment is to control the diabetic patient's blood glucose or sugarlevel. However, maintaining proper diabetes management may becomplicated because it has to be balanced with the activities of thediabetic patient.

For the treatment of type 1 diabetes, there are two principal methods ofdaily insulin therapy. In the first method, diabetic patients usesyringes or insulin pens to self-inject insulin when needed. This methodrequires a needle stick for each injection, and the diabetic patient mayrequire three to four injections daily. The syringes and insulin pensthat are used to inject insulin are relatively simple to use and costeffective.

Another effective method for insulin therapy and managing diabetes isinfusion therapy or infusion pump therapy in which an insulin pump isused. The insulin pump can provide continuous infusion of insulin to adiabetic patient at varying rates in order to more closely match thefunctions and behavior of a properly operating pancreas of anon-diabetic person that produces the required insulin, and the insulinpump can help the diabetic patient maintain his/her blood glucose levelwithin target ranges based on the diabetic patient's individual needs.

Infusion pump therapy requires an infusion cannula, typically in theform of an infusion needle or a flexible catheter, that pierces thediabetic patient's skin and through which, infusion of insulin takesplace. Infusion pump therapy offers the advantages of continuousinfusion of insulin, precision dosing, and programmable deliveryschedules.

In infusion therapy, insulin doses are typically administered at a basalrate and in a bolus dose. When insulin is administered at a basal rate,insulin is delivered continuously over 24 hours in order to maintain thediabetic patient's blood glucose levels in a consistent range betweenmeals and rest, typically at nighttime. Insulin pumps may also becapable of programming the basal rate of insulin to vary according tothe different times of the day and night. In contrast, a bolus dose istypically administered when a diabetic patient consumes a meal, andgenerally provides a single additional insulin injection to balance theconsumed carbohydrates. Insulin pumps may be configured to enable thediabetic patient to program the volume of the bolus dose in accordancewith the size or type of the meal that is consumed by the diabeticpatient. In addition, insulin pumps may also be configured to enable thediabetic patient to infuse a correctional or supplemental bolus dose ofinsulin to compensate for a low blood glucose level at the time when thediabetic patient is calculating the bolus dose for a particular mealthat is to be consumed.

Insulin pumps advantageously deliver insulin over time rather than insingle injections, typically resulting in less variation within theblood glucose range that is recommended. In addition, insulin pumps mayreduce the number of needle sticks which the diabetic patient mustendure, and improve diabetes management to enhance the diabeticpatient's quality of life.

Typically, regardless of whether a diabetic patient uses multiple directinjections (MDIs) or a pump, the diabetic patient takes fasting bloodglucose medication (FBGM) upon awakening from sleep, and also tests forglucose in the blood during or after each meal to determine whether acorrection dose is required. In addition, the diabetic patient may testfor glucose in the blood prior to sleeping to determine whether acorrection dose is required, for instance, after eating a snack beforesleeping.

To facilitate infusion therapy, there are generally two types of insulinpumps, namely, conventional pumps and patch pumps. Conventional pumpsrequire the use of a disposable component, typically referred to as aninfusion set, tubing set or pump set, which conveys the insulin from areservoir within the pump into the skin of the user. The infusion setconsists of a pump connector, a length of tubing, and a hub or base fromwhich a cannula, in the form of a hollow metal infusion needle orflexible plastic catheter extends. The base typically has an adhesivethat retains the base on the skin surface during use. The cannula can beinserted onto the skin manually or with the aid of a manual or automaticinsertion device. The insertion device may be a separate unit requiredby the user.

Another type of insulin pump is a patch pump. Unlike a conventionalinfusion pump and infusion set combination, a patch pump is anintegrated device that combines most or all of the fluidic components,including the fluid reservoir, pumping mechanism and mechanism forautomatically inserting the cannula, in a single housing which isadhesively attached to an infusion site on the patient's skin, and doesnot require the use of a separate infusion or tubing set. A patch pumpcontaining insulin adheres to the skin and delivers the insulin over aperiod of time via an integrated subcutaneous cannula. Some patch pumpsmay wirelessly communicate with a separate controller device (as in onedevice sold by Insulet Corporation under the brand name OmniPod®), whileothers are completely self-contained. Such devices are replaced on afrequent basis, such as every three days, when the insulin reservoir isexhausted or complications may otherwise occur, such as restriction inthe cannula or the infusion site.

As patch pumps are designed to be a self-contained unit that is worn bythe diabetic patient, it is preferable to be as small as possible sothat it does not interfere with the activities of the user. Thus, inorder to minimize discomfort to the user, it would be preferable tominimize the overall thickness of the patch pump. However, in order tominimize the thickness of the patch pump, its constituent parts shouldbe reduced as much as possible. One such part is the insertion mechanismfor automatically inserting the cannula into the user's skin.

In order to minimize the height of the insertion mechanism, someconventional insertion mechanisms are configured to insert the cannulaat an acute angle from the surface of the skin, e.g. 30-45 degrees.However, it may be preferable to insert the cannula perpendicular orclose to the perpendicular from the surface of the skin, since thiswould require the minimum length of cannula insertion. In other words,with the minimum length of cannula being inserted into the user's skin,the user can experience greater comfort and fewer complications, such aspremature kinking of the cannula. But one problem with configuring theinsertion mechanism to insert the cannula perpendicular to the surfaceof the skin is that this may increase the overall height of theinsertion mechanism, and therefore of the patch pump itself.

Accordingly, a need exists for an improved insertion mechanism for usein a limited space environment, such as in the patch pump, that cancost-effectively insert a cannula vertically or close to perpendicularlyinto the surface of a user's skin, while minimizing or reducing itsheight, in order to reduce the overall height of the device theinsertion mechanism is incorporated into, such as a patch pump.

SUMMARY OF THE INVENTION

The present invention is directed to a catheter insertion device for usewith an infusion set or patch pump. The invention is particularlydirected to a catheter insertion device having an actuator that ismanually depressed to insert the catheter by the use of an insertionneedle into the patient and to automatically retract the insertionneedle from the catheter when the catheter is deployed to apredetermined depth.

One embodiment of the invention is to provide an infusion set having aself-contained catheter insertion or introducing device that deploys thecatheter and retracts the insertion needle in a single operation by theuser.

Another feature of the invention is to provide a catheter insertiondevice having a manually operated actuator that is pressed by the userto insert the catheter into the patient and where the actuatorautomatically releases the introducer needle when the catheter is movedto an extended position to retract the introducer needle into thehousing of the device.

Another feature of the invention is to provide a catheter insertiondevice where a catheter and an insertion needle are movable between afirst retracted position and a second extended position. A catheter hubreceives an insertion needle during movement to the second positionwhere the needle then retracts at least partially from the catheter hub.A spring can be provided to automatically retract the needle withrespect to the catheter and catheter hub when the catheter and insertionneedle are deployed.

In one embodiment of the invention, the spring is initially in acompressed condition and is released by movement of the actuator afterdeployment of the catheter. The spring can be mounted to the base of thehousing or to the actuator. In one embodiment, the spring and a springretainer are coupled to the housing and configured so that the when thecatheter and needle are deployed, the catheter hub contacts the springretainer and separates from the spring to deploy the spring which thenretracts the needle into the actuator.

In another embodiment, the spring and spring retainer are coupled to theactuator. The spring is retained in the compressed condition by thespring retainer during movement of the actuator to an extended positionwhere the catheter and insertion needle penetrate the skin of thepatient. The spring retainer contacts the base of the housing when thecatheter and needle are completely extended to release and disengage thespring retainer from the spring. The spring is then allowed to expandand carry the needle away from the base and retract the needle from thecatheter.

These and other aspects of the invention are basically attained byproviding a catheter insertion device having a housing with a base, acatheter movable between a first retracted position and a secondextended position with respect to the housing, an introducer needlewithin the catheter and movable between a first retracted position and asecond extended position with respect to the base, and an actuator foractuating the device. A spring and spring retainer are disposed in thehousing to retain the spring in an initial compressed condition. Thecatheter and needle are coupled to the actuator and are movable betweena first position where the catheter and needle are retracted within thehousing and a second position where the catheter and needle extend fromthe housing, and where the retainer releases the spring when theactuator is moved to the second position to automatically retract theneedle into the actuator.

The various aspects of the invention are also attained by providing acatheter insertion device comprising a housing with a base, a catheter,an introducer needle and an actuator. The catheter is coupled to theactuator and is movable between a first retracted position and a secondextended position with respect to the housing. The introducer needle ispositioned within the catheter and is movable between a first retractedposition and a second extended position with respect to the base. Aspring and a spring retainer are disposed in the housing to retain thespring in an initial compressed condition. The needle is slidablyreceived within the actuator where the actuator is movable between afirst position where the catheter and needle are in the respective firstpositions within the housing, and a second position where the catheterand needle are in the respective second positions and the catheter hubengages the spring retainer to release the spring. The needle carrier isreleasably coupled to a distal end of the catheter. The needle carrieris separated from the catheter when the spring is released to retractthe needle into the actuator.

The features of the invention are also provided by a catheter insertiondevice comprising a housing having a base, and an actuator coupled tothe base. A catheter hub is coupled to the actuator and a cathetercoupled to the catheter hub where the actuator and catheter hub arebeing movable between a first position disposed where the catheter iswithin the base and a second position where the catheter extends fromthe base when the actuator is in the second position. An introducerneedle is slidably received in the actuator and slidable between a firstextended position with respect to the actuator and catheter holder, anda second retracted position where the needle carrier is releasablycoupled to the catheter hub. A spring and spring retainer for retainingthe spring in a compressed condition are positioned in the housing. Thecatheter hub is configured to release the spring to automaticallyretract the needle when the catheter and catheter hub are moved to thesecond position.

These and other aspects of the invention will become apparent from thefollowing detailed description of the invention which, taken inconjunction with the annexed drawings, show various embodiments of theinvention.

BRIEF DESCRIPTION OF THE DRAWINGS

The various objects, advantages and novel features of the exemplaryembodiments of the present invention will be more readily appreciatedfrom the following detailed description when read in conjunction withthe appended drawings, in which:

FIG. 1 is a perspective view of a patch pump incorporating a low-profilecannula insertion device, illustrated with a transparent cover forclarity;

FIG. 2 is an exploded view of the various components of the patch pumpof FIG. 1, illustrated with a cover;

FIG. 3 is a perspective view of an alternative design for a patch pumphaving a flexible reservoir, illustrated without a cover;

FIG. 4 is a patch-pump fluidic architecture and metering sub-systemdiagram of the patch pump of FIG. 3;

FIG. 5 is a perspective view of a patch pump or infusion set includingthe catheter insertion device in one embodiment of the invention;

FIG. 6 is a perspective view of the patch pump showing the actuator inthe deployed position;

FIG. 7 is a perspective view of the actuator of the catheter insertiondevice in one embodiment of the invention;

FIG. 8 is a partial cross-sectional view showing the insertion device inthe initial position with the spring in the compressed state;

FIG. 9 is a partial perspective view showing the catheter insertiondevice with the insertion needle coupled to the needle carrier;

FIG. 10 is a cross-sectional view showing the catheter and needle in theextended, partially deployed position;

FIG. 11 is a cross-sectional view showing the catheter and needle in thedeployed position and the catheter hub engaging the spring retainer torelease the spring;

FIG. 12 is a partial cross-sectional view showing the connecting portionof the insertion needle engaging an inner wall of the housing toseparate the needle from the needle retainer;

FIG. 13 is a cross-sectional view showing needle in the retractedposition;

FIG. 14 is a perspective view in a second embodiment of the inventionshowing the spring assembly coupled to the actuator;

FIG. 15 is a cross-sectional view showing the actuator and springassembly in the initial compressed state;

FIG. 16 is a cross-sectional view showing the actuator, catheter andneedle in the deployed position; and

FIG. 17 is a cross-sectional view showing the spring being released toretract the needle from the catheter.

DETAILED DESCRIPTION OF THE INVENTION

FIG. 1 is a perspective view of an exemplary embodiment of a patch pump1 according to an exemplary embodiment of the invention. The patch pump1 is illustrated with a see-through cover for clarity and illustratesvarious components that are assembled to form the patch pump 1. FIG. 2is an exploded view of the various components of the patch pump of FIG.1, illustrated with a solid cover 2. The various components of the patchpump 1 may include: a reservoir 4 for storing insulin; a pump 3 forpumping insulin out of the reservoir 4; a power source 5 in the form ofone or more batteries; an insertion mechanism 7 for inserting aninserter needle with a catheter into a user's skin; control electronics8 in the form of a circuit board with optional communicationscapabilities to outside devices such as a remote controller andcomputer, including a smart phone; a dose button 6 on the cover 2 foractuating an insulin dose, including a bolus dose; and a base 9 to whichvarious components above may be attached via fasteners 91. The patchpump 1 also includes various fluid connector lines that transfer insulinpumped out of the reservoir 4 to the infusion site.

It should be understood that inserter mechanisms come in variousconfigurations. In some embodiments, the inserter mechanism inserts asoft catheter into the skin. In these embodiments, typically the softcatheter is supported on a rigid insertion needle. The insertion needleis inserted into the skin along with the soft catheter, and thenretracted from the skin, leaving the soft catheter in the skin. In otherembodiments, a soft catheter is not provided, and the insertion needleremains in the skin and forms a portion of the insulin flow path todeliver insulin until the infusion is finished. Insertion needles aretypically hollow, and need to be hollow if they form part of the insulinflow path. However, insertion needles that support a soft catheter andthen retract may be solid or hollow. If the insertion needle deploys asoft catheter, and retracts but remains part of the insulin flow path,then the insertion needle should be hollow. However, if the insertionneedle deploys a soft catheter and then retracts but does not form partof the insulin flow path, then the insertion needle may be solid orhollow. In either case, the insertion needle is preferably rigid enoughto reliably penetrate the skin, but otherwise may be made flexibleenough to provide comfort to the user.

FIG. 3 is a perspective view of an alternative design for a patch pump1A having a flexible reservoir 4A, and illustrated without a cover. Sucharrangement may further reduce the external dimensions of the patch pump1A, with the flexible reservoir 4A filling voids within the patch pump1A. The patch pump 1A is illustrated with a conventional cannulainsertion device 7A that inserts the cannula, typically at an acuteangle, less than 90 degrees, at the surface of a user's skin. The patchpump 1A further comprises: a power source 5A in the form of batteries; ametering sub-system 41 that monitors the volume of insulin and includesa low volume detecting ability; control electronics 8A for controllingthe components of the device; and a reservoir fill port 43 for receivinga refill syringe 45 to fill the reservoir 4A.

FIG. 4 is a patch-pump fluidic architecture and metering sub-systemdiagram of the patch pump 1A of FIG. 3. The power storage sub-system forthe patch pump 1A includes batteries 5A. The control electronics 8A ofthe patch pump 1A may include a microcontroller 81, sensing electronics82, pump and valve controller 83, sensing electronics 85, and deploymentelectronics 87 that control the actuation of the patch pump 1A. Thepatch pump 1A includes a fluidics sub-system that may include areservoir 4A, volume sensor 47 for the reservoir 4A, a reservoir fillport 43 for receiving a refill syringe 45 to refill the reservoir 4A.The fluidics sub-system may include a metering system comprising a pumpand valve actuator 411 and an integrated pump and valve mechanism 413.The fluidics sub-system may further include an occlusion sensor, adeploy actuator, as well as the cannula 47 for insertion into aninfusion site on the user's skin. The architecture for the patch pumpsof FIGS. 1 and 2 is the same or similar to that which is illustrated inFIG. 4.

The present invention is directed to a catheter insertion device for usewith the infusion set or patch pump. The invention is particularlydirected to a catheter insertion device having an actuator that ismanually depressed to insert the catheter into the patient andautomatically release a spring to retract the insertion needle from thecatheter into the actuator.

Referring to FIGS. 5-13, a patch pump, also referred to herein as aninfusion set 10, is provided for introducing a drug or pharmaceutical toa patient need thereof. The infusion set of the invention can be for usewith insulin injection systems, although other drugs or pharmaceuticalscan be delivered to the patient. The infusion set contains a suitabledispensing mechanisms, storage containers and metering devices forextended delivery of the drug or pharmaceutical to the patient as knownin the art. The invention is further directed to a method of inserting acatheter using the insertion device.

A housing 12 has a base 14 with an internal cavity for containing thefluid supply or reservoir and metering mechanisms for deliveringinsulin, drug, pharmaceutical or other medicament to the patient. Acatheter insertion device 18 is mounted within the housing 12 and thebase 14. In the embodiment shown, the base 14 is constructed to contactthe skin of the patient for delivering the medicament to the patient.

The catheter insertion device 18 includes an actuator 26, a deliverydevice shown as a catheter 28, and an insertion needle 30. In theembodiment of the invention as shown, the delivery device is a flexiblecatheter 28 as known in the art having a dimension and length suitablefor delivering insulin or other drugs and pharmaceuticals through theskin of a patient with minimal discomfort to the patient. Flexiblecatheters are generally preferred to reduce the discomfort to thepatient. In other embodiments, the delivery device can be a rigidcannula or lumen.

Catheter 28 has a first proximal end 32 and a second distal outer end34. A fluid passage extends between the ends for delivering the insulinor other drug or pharmaceutical to the patient. First end 32 of catheter28 is coupled to a catheter hub 36 as shown in FIG. 8. Catheter hub 36has a substantially cylindrical shape in the embodiment shown forsliding movement within housing 12. Catheter hub 36 has a passageextending between a first end 38 and a second end 40 having a cavity forreceiving a generally funnel shaped member 42. Funnel shaped member 42has a neck 44 inserted into the passage of catheter 28 at the firstproximal end 32 by a friction fit or adhesive to couple catheter 28 tocatheter hub 36. Funnel shaped member 42 has an upper end 46 with aseptum 48.

Insertion needle 30 is received in the passage of catheter 28 and has alength to extend past distal end 34 of catheter 28 as shown in FIG. 8.Insertion needle 30 in the embodiment shown is a steel cannula having aninternal passage for delivering insulin or other pharmaceutical agentsto catheter 28 and to the patient. Insertion needle 30 has a pointeddistal end 50 with a sharp tip 52 for penetrating the skin of thepatient to assist in inserting flexible catheter 28 into the skin of thepatient as shown in FIG. 10. Insertion needle 30 passes through septum48 to provide a fluid tight seal between insertion needle 30 andcatheter 28 as known in the art. As shown in FIG. 8, insertion needle 30has a connecting section 54 connected to the delivery device and fluidsupply, such as the supply shown in FIG. 3, contained within the housing12 for delivering the insulin or pharmaceutical agent to the patient. Asshown in the drawings, insertion needle 30 is mounted for slidingmovement within actuator 26 and housing 12 in a substantially lineardirection. In one embodiment as shown, insertion needle 30 travels in adirection substantially perpendicular to the plane of the base 14. Theconnecting portion 54 is received in a slot or notch in catheter hub 36by a friction fit so that needle 30 travels with catheter hub 36 andcatheter 28 until separated.

Actuator 26 is in the form of a button or other manually actuated memberthat is depressed or actuated by the patient during use and deploymentand insertion of the catheter 28 into the patient. Actuator 26 ismovable from a first position shown in FIG. 8 to an actuated or deployedposition shown in FIGS. 10 and 11. Actuator 26 in the embodiment shownhas a substantially cylindrical configuration and is received within anopening 56 in a top face of housing 12 for sliding movement withinopening 56.

In the embodiment shown, actuator 26 has a cylindrical outer side wall58 with a top wall 60 and a bottom distal end 62. Outwardly extendingbreakable or resilient tabs 20 are received in corresponding recesses 22in housing to require a predetermined force to depress actuator 26 asshown in FIGS. 7 and 9. Cylindrical side wall 58 defines an interiorannular cavity 64. In one embodiment of the invention, a substantiallycylindrical shaped inner sleeve 66 extends from top wall 60 towarddistal end 62 of the side wall 58 and is spaced inwardly from outer sidewall 58. Sleeve 66 is concentric with side wall 58 and spaced inwardlyto define annular cavity 64. In one embodiment, sleeve 66 has a lengthless than a length of side wall 64 so that the end of the sleeve 66 isspaced from bottom distal end 62 a distance complementing the dimensionof catheter hub 36 so that the hub 36 is received within the actuator asshown in FIG. 8.

In the embodiment shown, a cylindrical wall 68 is provided withinhousing 12 for defining a cavity 70 or passage for receiving actuator 26and allowing sliding movement of actuator 26 with respect to the housing12 and base 14. In one embodiment, cylindrical wall 68 is integrallyformed with base 12. Cylindrical side wall 68 is provided with a recessat a top end and a recess or rib 24 toward a bottom end at or near base14 as shown in FIG. 12. The outwardly extending detent 20 can beprovided to project outwardly from side wall 58 and has a dimension tobe received in the respective recesses to retain the actuator in thedeployed position. Other mechanisms can be used to retain or lock theactuator in a deployed position such as by a hook 25 that mates with acorresponding recess or tab on an inner surface of wall 68.

Insertion needle 30 is coupled to a needle carrier which is formed aspart of catheter hub 36. In the embodiment shown, needle carrier has acylindrical shape forming a sleeve that slides within cavity 74 of innerwall 81. The needle carrier is formed by a V-shaped notch 76 shown inFIG. 10 having a dimension to receive connecting portion 54 of needle 30so that downward movement of catheter hub 36 carries insertion needle 30to the second extended position. The connecting portion 54 can bereceived in the notch 76 by a friction fit. Connecting portion 54 ofneedle 30 in the embodiment shown extends substantially perpendicular tothe main longitudinal portion of needle 30 and is connected to the fluidsupply for introducing the fluid to the catheter during use. As shown inFIGS. 8 and 9, inner sleeve 66 of actuator 26 has a longitudinal slot 80to enable connecting portion 54 of needle 30 to slide within actuator 26in a linear direction along the longitudinal dimension of the slot 80.

Housing 12 is provided with an inner wall 81 concentric with wall 68 toform an axial passage 82 for catheter hub 36 and inner sleeve 66 ofactuator as shown in FIG. 8. In one embodiment, inner wall 81 isconnected to base 12 by a connecting portion 83. Inner wall 81 has a topend at the top face of housing 12 for receiving actuator and guidingactuator 26 while actuator 26 moves between the first position and thesecond position. As shown in FIGS. 8 and 10, inner wall 81 includesopenings 84 at the bottom end adjacent base 14 formed by the connectingportions 83. In the embodiment shown, the distal end of inner sleeve 66of actuator 26 is coupled to catheter hub 36 so that catheter hub 36moves with actuator 26 to the extended position when the device isdeployed.

A biasing member is provided to bias insertion needle 30 upwardly withrespect to the bottom wall. A spring 90 and a spring retainer 92 areprovided within housing 12 and within the cavity 70 defined by innerwall 68. As shown in FIGS. 8, 10 and 11, spring 90 is a coil springsurrounding inner wall 81, the center axis of cavity 70 and the openingprovided in base 12 for the catheter 28 and needle 30. Spring retainer92 can be made from a flexible or deformable material having a bottomwall 94 with an aperture 96 to receive catheter 28 and needle 30. Atleast one and typically three flexible and bendable legs 98 extendupwardly from bottom wall 94. Each leg 98 is provided with an outwardlyextending tab 100 having a bottom face 102, a top face 104 and an innerface 106. Bottom face 102 extends substantially parallel to base 12 inthe rest position to capture spring 90 between tabs 100 and base 12, asshown in FIG. 8 and FIG. 10. Inner face 106 in the initial positioncontacts the outer edge of inner wall 81 to retain legs 98 in theoutward position shown in FIG. 8. In the embodiment shown, spring 90 isinitially in a compressed state so that spring 90 biases spring retainer92 in an upward direction toward and into contact with the bottom end ofinner wall 81 shown in FIG. 10. In the embodiment shown, legs 98 engagean outer surface of inner wall 81 to retain legs 98 flexed outward tothe position shown in FIG. 8 to retain spring 90 in the compressedstate. In the embodiment shown, the bottom edge of inner wall 81 has aslight taper complementing the slight outward taper of inner surfaces106 of legs 98.

During use, the infusion set is positioned against the skin of thepatient by an adhesive in the desired location. Initially, actuator 26is in the position shown in FIG. 8 extending above the top face ofhousing 12 with catheter 28 and needle 30 retracted within housing 12.The device is deployed by the user pressing in a downward direction onactuator 26. The downward force on actuator 26 pushes catheter hub 36with needle 30 removably coupled to catheter hub 36 to an extendedposition shown in FIG. 10 where the distal end of catheter hub 36contacts bottom wall 94 of spring retainer 92 and needle 30 and thecatheter penetrates the skin of the patient. At this point, furthermovement of actuator 26 pushes spring retainer 92 downward toward base12 and away from inner wall 81 to the position shown in FIG. 11. Asshown in FIG. 12, inner wall 81 has a longitudinal slot 108 to enableconnecting portion 54 of needle 30 to slide along the length of innerwall 81. In FIG. 12, spring retainer 92 is not shown for clarity. Springretainer 92 is normally positioned with spring 90 as shown in FIG. 8. Abottom edge 110 of slot 108 is spaced from the base 12 a distance sothat connecting portion 54 contacts bottom edge 110 as actuator 26 ismoved to the position shown in FIG. 11 to separate needle 30 fromcatheter hub 36. The downward movement of actuator 26 and catheter hub36 to the position shown in FIG. 11 separates connecting portion 54 fromnotch 76 in needle carrier 36 as shown in FIG. 12 to allow connectingportion 54 and needle 30 to retract by the spring 90 within the innerwall 81 and the inner sleeve 66. In this position, inner face 106 of thetabs 100 are separated from the inner wall 81 so that tabs 100 deflectinwardly toward each other and the center axis of spring retainer 92 sothe bottom face 102 of tabs 100 are separated from the end of spring 90,thereby allowing spring 90 to expand to the position shown in FIG. 13.Spring 90 engaging the bottom surface 102 biases legs 98 inwardly sothat spring 90 slides over the tabs 100. The expansion of spring 90enables the top end of spring 90 to engage connecting portion 54 ofneedle 30 and retract the needle 30 from catheter 28 into the cavity ofinner sleeve 66. In preferred embodiments, needle 30 remains at leastpartially within catheter 38 for supplying a pharmaceutical agentthrough catheter 28 to the patient.

In another embodiment of the invention shown in FIGS. 14-17, thecatheter insertion device is included in an infusion set 120 having ahousing 122 and a base 124 in a manner similar to the previousembodiment. An actuator 126 is slidably received in an opening 128 inhousing 122.

A catheter 130 is coupled to a catheter hub 132 which is coupled toactuator 126. Actuator 126 includes an outer wall 134 and an inner wall136. Inner wall 136 includes a longitudinal slot 138 for slidablyreceiving a connecting portion 140 of the introducer needle 142. Outerwall 134 includes a longitudinal slot 139 aligned with slot 138 forreceiving the connecting portion 140 as shown in FIGS. 15-17. Needle 142extends through a septum 144 received within catheter hub 132. A funnelis received in catheter hub 132 and is connected to catheter 132 as inthe previous embodiment. In one embodiment, catheter 130 is a flexiblecatheter suitable for introducing a substance to a patient. Housing 122has an inner wall 146 defining a cavity 148 to receive actuator 126 in asliding manner as in the previous embodiment. A slot 150 extends thelongitudinal length of inner wall 146 to allow connecting portion 140 ofneedle 142 to slide between a retracted position shown in FIG. 15 and anextended position shown in FIG. 16. Needle 142 is connected to aflexible supply tube 143 that is connected to a reservoir and pump as inthe previous embodiment.

A biasing member is provided to bias needle 142 away from base 124 andto retract needle 142 with respect to catheter 130. A spring 152 andspring retainer 154 are coupled to actuator 126 to define a biasingmember for retracting needle 142 from catheter 130. In the embodimentshown, spring 152 is a coil spring which is initially in a compressedstate surrounding catheter hub 132. In this embodiment, spring retainer154 is in the form of an outwardly extending flange extending radiallyoutward from catheter hub 132 and forming a surface for contact with abottom end of spring 152. Spring retainer 154 can be integrally formedwith catheter hub 132. An annular shaped disc 156 slides on inner wall136 within the annular cavity formed between outer wall 134 and 136.Disc 156 defines a surface for contacting a top end of spring 152. A topface of disc 156 includes a radially extending recess for receivingconnecting portion 140 of needle 142. A movable latch 158 is coupled tospring retainer 154 as shown in FIG. 15. As shown in FIG. 14, threelatches 158 are spaced equally around the perimeter of disc 156. Movablelatch 158 has a top end with an inwardly extending hook 160 for hookingonto the top surface of disc 156 as shown in FIG. 15. A bottom end oflatch 156 has an outwardly extending leg 162. In one embodiment, movablelatch 158 is able to pivot around the distal end of leg 162 so that hook160 is able to move radially outward to release and disengage disc 156.

During use, infusion set 120 is positioned on the skin of the patient inthe desired location. Actuator 126 is manually depressed downward towardthe skin of the patient to deploy catheter 130 and needle 142. Thedownward force pushes catheter hub 132 and disc 156 toward base 124 sothat catheter 130 and insertion needle 140 to penetrate the skin of thepatient as shown in FIG. 16. Actuator 126 is moved to the position shownin FIG. 16 where latch 156 contacts base 124 and pivots outwardly tounhook from disc 156 thereby releasing disc 156 and spring 152. Spring152 then expands carrying disc 156 and needle 142 to the retractedposition shown in FIG. 17.

In one embodiment, each latch 158 is coupled to or integrally formedwith spring retainer 154 and spaced outwardly from catheter holder 132.The downwardly movement of catheter holder 132 causes the bottom end oflatch 158 to contact bottom wall 124 in the extended deployed position.Contact of latch 158 with bottom wall 124 causes an outwardly pivotingmovement of latch 158 away from spring retainer 156 to release springretainer 156 and spring 152. The downward movement of actuator 126 andthe force applied to disc 156 releases the tension between hook 160 oflatch 158 and disc 156 to allow hook 160 to separate from disc 156. Inone embodiment, latch 158 in a rest position extends at an outward anglefrom catheter hub 132 in the position shown in FIG. 16. The latches 158in the loaded position shown in FIG. 15 are pushed inwardly so that hook160 engages disc 156. Spring 152 biases disc 156 into contact with hook160 so that hook 160 is retained in the latched position shown in FIG.15. The downward force of catheter hub 132 and disc 156 can releasetension on spring 152 to enable latch 158 to move away from catheter hub132 to disengage hook 160 from disc 156.

While various embodiments have been shown and described, it will beunderstood by those skilled in the art that various changes andmodifications can be made without departing from the scope of theinvention as defined in the appended claims.

1. A catheter insertion device comprises: a housing having a base: acatheter movable between a first retracted position and a secondextended position with respect to said base; an introducer needle withinsaid catheter and movable between a first retracted position and asecond extended position with respect to said base and catheter; aspring disposed in said housing; a spring retainer for retaining saidspring in a compressed state; and an actuator for actuating said device,said catheter and needle being coupled to said actuator and beingmovable between a first position where said catheter and needle areretracted within said actuator, and a second position where saidcatheter and needle extend from said base, and where said retainerreleases said spring when said actuator is moved to said second positionto automatically retract said needle.
 2. The device of claim 1, furthercomprising a catheter hub coupled to said actuator and having a firstend contacting said actuator and a second distal end, said catheterbeing coupled to said catheter hub.
 3. The device of claim 1, furthercomprising a catheter hub having a first end engaging said actuator anda second end, said catheter extending from said second end, wherein saidcatheter hub contacts said spring retainer when said actuator is in saidsecond position to release said spring.
 4. The device of claim 3,wherein comprising said spring retainer is deformable and includes aplurality of legs with an outwardly extending tab engaging and end ofsaid spring, and where said catheter hub engages said spring retainer todeflect said tabs and release said spring.
 5. The device of claim 4,wherein said spring is expandable to retract said introducer needle withrespect to said catheter.
 6. The device of claim 5, wherein said springis captured in a compressed state between said base and said tab of saidlegs when said actuator is in said first position, and where saidcatheter retainer contacts said spring retainer to deflect said tabsinwardly to release said spring whereby said spring engages said needleto retract said needle.
 7. The device of claim 6, wherein said catheterhub has a slot at said first end with a dimension to frictionally engagesaid introducer needle whereby said needle is carried by said catheterhub during movement to said second position, and where said springcontacts said needle to bias said needle away from said catheter hub. 8.A catheter insertion device comprising: a housing having a base; acatheter movable between a first retracted position and a secondextended position with respect to said base; an introducer needle withinsaid catheter and movable between a first retracted position and asecond extended position with respect to said base; a spring disposed insaid housing; a spring retainer in said housing and retaining saidspring in a compressed state; and an actuator movable with respect tosaid base, said catheter being coupled to and movable with saidactuator, and said needle being slidably received in said actuator, saidactuator being movable between a first position where said catheter andneedle are in the respective first positions within the base and asecond position where said catheter and needle are in the respectivesecond positions to engage said spring retainer and release said spring,said needle being slidable in said actuator when said spring is releasedto retract said needle.
 9. The device of claim 8, further comprising acatheter hub coupled to said actuator and having a first end contactingsaid actuator and a second distal end, said catheter being coupled tosaid catheter hub.
 10. The device of claim 9, wherein said spring is acoil spring surrounding said spring retainer.
 11. The device of claim 9,wherein said actuator has an inner sleeve with an axial passage slidablyreceiving said needle, said inner sleeve defining an annular cavity insaid actuator.
 12. The device of claim 9, wherein said spring retainerhas a bottom wall with an aperture for receiving said catheter andneedle, a side wall extending away from said bottom wall, and aplurality of tabs extending outwardly from a top edge of said side wall,wherein said tabs engage a top end of said spring to retain said springin said compressed state.
 13. The device of claim 12, wherein saidhousing has an inner sleeve receiving said catheter and needle, saidinner sleeve having a distal end contacting said tabs of said springretainer, and where said catheter hub contacts said bottom wall of saidspring retainer to separate said tabs from said spring.
 14. The deviceof claim 13, wherein said inner sleeve has a longitudinal slot, andwhere said needle is slidably received in said slot for movement betweensaid first position and second position, wherein said spring slidesaround said inner sleeve when separated from said spring retainer andcontacts said needle to retract said needle.
 15. A catheter insertiondevice comprising: a housing having a base; an actuator coupled to saidbase; a catheter hub coupled to said actuator and a catheter coupled tosaid catheter hub, said actuator and catheter hub being movable betweena first position disposed within said housing and a second positionwhere said catheter extends from said housing when said actuator is insaid second position; an introducer needle slidably received in saidactuator and slidable between a first extended position with respect tosaid actuator and catheter hub, and a second retracted position wheresaid sleeve is releasably coupled to said catheter hub; and a spring anda spring retainer for contacting said spring, said catheter hub beingconfigured to release said spring retainer to automatically retract saidneedle when said catheter hub is moved to said second position.
 16. Thedevice of claim 15, wherein said spring retainer is coupled to saidcatheter hub and separable from said catheter hub when said catheter hubis moved to the second position.
 17. The device of claim 15, whereinsaid spring retainer is slidable relative to said actuator and ismovable between said first position and second position.
 18. The deviceof claim 15, wherein said catheter hub has a bottom end with anoutwardly extending flange and a movable latch coupled to said catheterhub with an inwardly extending tab engaging said spring retainer,wherein said spring is retained between said flange and said tab in thecompressed state.
 19. The device of claim 18, wherein said movable latchseparates from said spring retainer when said catheter hub contacts saidbase of said housing to release said spring retainer and spring toretract said needle.